Se-tan Plus
Multivitamin/mineral
Seton Pharmaceuticals
Human Prescription Drug
NDC 13925-118Se-tan Plus also known as Multivitamin/mineral is a human prescription drug labeled by 'Seton Pharmaceuticals'. National Drug Code (NDC) number for Se-tan Plus is 13925-118. This drug is available in dosage form of Capsule, Gelatin Coated. The names of the active, medicinal ingredients in Se-tan Plus drug includes Calcium Pantothenate - 10 mg/1 Cupric Sulfate - .8 mg/1 Cyanocobalamin - 15 ug/1 Ferrous Fumarate - 162 mg/1 Folic Acid - 1 mg/1 Iron Dextran - 115.2 mg/1 Manganese Sulfate - 1.3 mg/1 Niacinamide - 30 ug/1 Pyridoxine Hydrochloride - 5 mg/1 Riboflavin - 6 mg/1 and more. The currest status of Se-tan Plus drug is Active.
Drug Information:
| Drug NDC: | 13925-118 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Se-tan Plus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Multivitamin/mineral |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Seton Pharmaceuticals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Gelatin Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM PANTOTHENATE - 10 mg/1
CUPRIC SULFATE - .8 mg/1
CYANOCOBALAMIN - 15 ug/1
FERROUS FUMARATE - 162 mg/1
FOLIC ACID - 1 mg/1
IRON DEXTRAN - 115.2 mg/1
MANGANESE SULFATE - 1.3 mg/1
NIACINAMIDE - 30 ug/1
PYRIDOXINE HYDROCHLORIDE - 5 mg/1
RIBOFLAVIN - 6 mg/1
Load more...SODIUM ASCORBATE - 200 mg/1
THIAMINE MONONITRATE - 10 mg/1
ZINC SULFATE - 18.2 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Oct, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Seton Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | M0022794
N0000175951
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 568ET80C3D
LRX7AJ16DT
P6YC3EG204
R5L488RY0Q
935E97BOY8
95HR524N2M
W00LYS4T26
25X51I8RD4
68Y4CF58BV
TLM2976OFR
Load more...S033EH8359
8K0I04919X
89DS0H96TB
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Vitamin B12 [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Vitamin B 12 [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Analogs/Derivatives [Chemical/Ingredient]
Ascorbic Acid [CS]
Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
Iron [CS]
Magnetic Resonance Contrast Activity [MoA]
Paramagnetic Contrast Agent [EPC]
Parenteral Iron Replacement [EPC]
Phosphate Binder [EPC]
Phosphate Chelating Activity [MoA]
Vitamin B 12 [CS]
Vitamin B 6 [Chemical/Ingredient]
Vitamin B12 [EPC]
Vitamin B6 Analog [EPC]
Vitamin C [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 13925-118-90 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (13925-118-90) | 01 Oct, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Se-tan plus multivitamin/mineral ferrous fumarate ferrous cation iron dextran ferric cation sodium ascorbate ascorbic acid thiamine mononitrate thiamine ion thiamine riboflavin riboflavin pyridoxine hydrochloride pyridoxine cyanocobalamin cyanocobalamin folic acid folic acid niacinamide niacinamide calcium pantothenate pantothenic acid zinc sulfate zinc cation manganese sulfate manganese cation (2+) cupric sulfate cupric cation fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 gelatin magnesium stearate cellulose, microcrystalline silicon dioxide titanium dioxide t503
Drug Interactions:
Drug interactions prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
Boxed Warning:
Warning: accidental overdose of iron-containing products is the leading cause of fatal poisoning in children under six. keep this and all drugs out of reach of children. in case of accidental overdose, call a doctor or poison control center immediately.
Indications and Usage:
Indications and usage: se-tan plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. also for treatment of condition in which iron deficiency and vitamin c deficiency occur together, along with a deficient intake or increased need for b-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
General Precautions:
General: folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.
Dosage and Administration:
Dosage and administration: adults (persons over 12 years of age), one (1) capsule daily, orally, between meals, or as prescribed by a physician. do not exceed recommended dosage. do not administer to children under the age of 12.
Contraindications:
Contraindications : se-tan plus is contraindicated in patients with a known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
Adverse Reactions:
Adverse reactions: folic acid: allergic sensitizations have been reported following both oral and parenteral administration of folic acid. ferrous fumarate: gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. although the absorption of iron is best when taken between meals, giving se-tan plus after meals may control occasional g.i. disturbances. se-tan plus is best absorbed when taken at bedtime.
Drug Interactions:
Drug interactions prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones.
Pediatric Use:
Pediatric use: safety and effectiveness of this product have not been established in pediatric patients.
Geriatric Use:
Geriatric use: no clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases.
Overdosage:
Overdose: iron: signs and symptoms: iron is toxic. acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. the estimated overdose of orally ingested iron is 300-mg/kg body weight. when overdoses are ingested by children, severe reactions, including fatalities, have resulted. se-tan plus should be stored beyond the reach of children to prevent against accidental iron poisoning. keep this and all other drugs out of the reach of children. treatment: for specific therapy, exchange transfusion and chelating agents should be used. for general management, perform gastric lavage with sodium bicarbonate solution or milk. administer intravenous fluids and electrolytes and use oxygen.
Description:
Description: se-tan plus are white capsules imprinted in black "t503". each capsule contains: supplement facts servings per bottle: 90 serving size: 1 capsule each capsule contains: â%dv for âadults iron (as ferrous fumarate anhydrous) 32.5 mg 181% polysaccharide iron complex 115.2 mg 642% vitamin c (sodium ascorbate) 200 mg 222% vitamin b 1 (thiamine mononitrate) 10 mg 833% vitamin b 2 (riboflavin) 6 mg 462% vitamin b â6 â (pyridoxine hcl) 5 mg 294% vitamin b â12 â (cyanocobalamin concentrate) 15 mcg 250% folate (folic acid) 1000 mcg 250% niacinamide 30 mg 188% pantothenic acid (as calcium panothenate) 10 mg 200% zinc ( as zinc sulfate) 18.2 mg 165% manganese (as manganese sulfate) 1.3 mg 57% copper (as copper sulfate) 0.8 mg 89%
Clinical Pharmacology:
âclinical pharmacology oral iron is absorbed most efficiently when administered between meals. iron is critical for normal hemoglobin synthesis to maintain oxygen transport, energy production and proper function of cells. adequate amounts of iron are necessary for effective erythropoiesis. iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. folic acid is required for nucleoprotein synthesis and the maintenance of normal eryhtropoiesis. folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. deficiency of folic acid may account for the defective deoxyribonucleic acid (dna) synthesis that leads to megaloblast formation and megaloblasticmacrocytic anemias. vitamin b â12 â is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and mylein synthesis. deficiency ma
Read more...y result in megaloblastic anemia or pernicious anemia.
How Supplied:
How supplied: se-tan plus are white capsules imprinted in black "t503". child resistant bottles of 90 capsules. product code: ndc 13925-118-90. â âpharmacist: dispense in a tight, light-resistant container as defined in the usp/nf with a child-resistant closure.
Package Label Principal Display Panel:
Principal display panel ndc 13925- 118 -90 se-tan-plus ferrous fumarate / polysaccharide iron complex / multivitamin mineral capsules 90 capsules rx only seton pharmaceuticals container label